Certain Respiratory Conditions: The possibility that TALWIN may cause respiratory depression should be considered in treatment of patients with bronchial asthma. TALWIN should be administered only with caution and in low dosage to patients with respiratory depression (e.g., from other medication, uremia, or severe infection), severely limited respiratory reserve, obstructive respiratory conditions, or cyanosis.

Impaired Renal or Hepatic Function: Although laboratory tests have not indicated that TALWIN causes or increases renal or hepatic impairment, the drug should be administered with caution to patients with such impairment. Extensive liver disease appears to predispose to greater side effects (e.g., marked apprehension, anxiety, dizziness, sleepiness) from the usual clinical dose, and may be the result of decreased metabolism of the drug by the liver.

Biliary Surgery: Narcotic drug products are generally considered to elevate biliary tract pressure for varying periods following their administration. Some evidence suggests that pentazocine may differ from other marketed narcotics in this respect (i.e., it causes little or no elevation in biliary tract pressures). The clinical significance of these findings, however, is not yet known.

Patients Receiving Narcotics: TALWIN is a mild narcotic antagonist. Some patients previously given narcotics, including methadone for the daily treatment of narcotic dependence, have experienced withdrawal symptoms after receiving TALWIN.

CNS Effect: Caution should be used when TALWIN is administered to patients prone to seizures; seizures have occurred in a few such patients in association with the use of TALWIN although no cause and effect relationship has been established.

Use in Anesthesia: Concomitant use of CNS depressants with parenteral TALWIN may produce additive CNS depression. Adequate equipment and facilities should be available to identify and treat systemic emergencies should they occur.

Usage in Pregnancy:

Safe use of TALWIN during pregnancy (other than labor) has not been established. Animal reproduction studies have not demonstrated teratogenic or embryotoxic effects. However, TALWIN should be administered to pregnant patients (other than labor) only when, in the judgment of the physician, the potential benefits outweigh the possible hazards. Patients receiving TALWIN during labor have experienced no adverse effects other than those that occur with commonly used analgesics. TALWIN should be used with caution in women delivering premature infants.

Pediatric Use:

The safety and efficacy of TALWIN as preoperative or preanesthetic medication have been established in pediatric patients 1 to 16 years of age. Use of TALWIN in these age groups is supported by evidence from adequate and controlled studies in adults with additional data from published controlled trials in pediatric patients. The safety and efficacy of TALWIN as a premedication for sedation have not been established in pediatric patients less than one year old. Information on the safety profile of TALWIN as a postoperative analgesic in children less than 16 years is limited.

Geriatric Use:

Elderly patients may be more sensitive to the analgesic effects of TALWIN than younger patients. (See DOSAGE AND ADMINISTRATION.)

Clinical data indicate that differences in various pharmacokinetic parameters of TALWIN may exist between elderly and younger patients. (See CLINICAL PHARMACOLOGY.)

Sedating drugs may cause confusion and oversedation in the elderly; elderly patients generally should be started on low doses of TALWIN and observed closely.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.